Single-insertion, multiple sample biopsy device with integrated markers

ABSTRACT

The present invention provides for exemplary embodiments of a single-insertion, multiple sample biopsy device. Exemplary embodiments of a single-insertion, multiple sampling device with integrated marker release.

PRIORITY DATA AND INCORPORATION BY REFERENCE

This application claims benefit of priority to U.S. Provisional PatentApplication Ser. No. 60/707,229 filed Aug. 10, 2005 which isincorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to a tissue biopsy sampling device.

BACKGROUND OF THE INVENTION

Often, it is either desirable or necessary to obtain specimens of tissuefrom humans and other animals, particularly in the diagnosis andtreatment of patients with cancerous tumors, premalignant conditions,and other diseases or disorders. For example, when it is discovered thatsuspicious conditions exist, either by means of x-ray or ultrasoundimaging in various tissues of the body, a physician typically performs abiopsy to determine if the cells at the suspected site are cancerous.

A biopsy can be done either by an open or percutaneous technique. Openbiopsy is an invasive procedure using a scalpel, whereby either aportion (incisional biopsy) or the entire mass (excisional biopsy) isremoved. Percutaneous biopsy is usually done with a needle-likeinstrument through a relatively small incision, and can be performed byfine needle aspiration (FNA) or through the taking of a core biopsysample. In FNA biopsy, individual cells or clusters of cells areobtained for cytologic examination and can be prepared such as in aPapanicolaou smear. In a core biopsy, a core or fragment of the tissueis obtained for histologic examination.

Intact tissue from the organ, lesion, or tumor is preferred by medicalpersonnel in order to arrive at a definitive diagnosis regarding thepatient's condition. In most cases only part of the tissue in questionneeds to be sampled. The portions of tissue extracted must be indicativeof the organ, lesion, or tumor as a whole. Often, multiple tissuesamples from various locations of the mass being sampled may be taken.

The percutaneous biopsy procedure can be performed utilizing varioustechniques and devices. One such biopsy device can include an innerstylet positioned inside an cutting cannula, whereby the stylet is ableto slide into and out of the cannula. The stylet can be a solid, pointedneedle having a tissue sampling recess, and the cannula can be a hollow,open-ended needle having a sharp tip. The stylet and cannula can bemanipulated cooperatively to capture a tissue sample in the samplerecess. Such existing devices can be manually operated, semi-automated,and automated.

U.S. Pat. No. 6,485,436 shows a multiple sample biopsy needle with ahydraulic mechanism that circulates fluid from the tip of the needleback to a receiving basket or baskets. A revolver-type array ofreceiving chambers is disclosed.

U.S. Pat. No. 5,827,305 shows a tissue sampling needle that pushes asample proximally using a saline wash. Samples remain spaced apartwithin the needle such that the sequence of their collection ispreserved. Samples can also be removed from a port while the needleremains in place. No mechanical transport mechanisms or drives aredisclosed.

U.S. Pat. No. 5,526,822 shows a transport system that uses a cannula andknock-out pin combined with a vacuum source to shuttle a tissue sampleto a multiple-chamber cassette where it is knocked out. The cannula isthen repositioned for another sample. The vacuum source is external. Arevolving sample cassette is also shown. A vent opening in each samplecylinder of the cassette is provided to eject the fluid used totransport the tissue sample. A removable disposable needle-bearingcassette interfaces with rotary and linear drives by means of long gearsand shuttles that cradle the gears. Cutters operate in rotary and linearfashion (a counter-rotating cutters embodiment is included) and thecannula can be rotated to orient the sample opening.

U.S. Pat. No. 6,017,316 shows a transport system similar to U.S. Pat.No. 5,827,822 in which a cutter transports with vacuum assist. Multiplesampling with single insertion is described but not automated multiplesample-handling. The details of a drive system are not disclosed

U.S. Pat. No. 6,193,673 shows a needle with a durable part and adisposable part. An external cutting cannula rotates and advancesaxially to cut a sample. The tissue cutter is driven axially by a rackand pinion drive which are part of a durable component. A cradleconnects the rack to the cutting cannula.

U.S. Pat. No. 5,944,673 describes a tissue extractor that rotates withina piercing needle to align with any one of multiple receiving portswhile obstructing the remaining ports. The tissue sample is cut byadvancing the cutter and removing by withdrawing the extractor. A vacuumholds the tissue sample in place during the removal of the tissueextractor from the cutter. The cutter rotates as it advances.

It is known to obtain a single sample with a single insertion. However,there are circumstances where there may be a need to obtain more thanone samples. While the known biopsy needle can be re-inserted multipletimes, such technique can cause pain and scarring of the body site.

It is known to leave a marker at the biopsied site. To do so, however, aphysician or healthcare provider would typically need to withdraw thebiopsy needle and insert a different device to leave a marker at thebiopsied site. The additional step and device may not allow the markerto be deposited at the actual biopsied site, which can lead toinaccurate post-biopsy diagnosis.

SUMMARY OF THE INVENTION

The present invention provides for exemplary embodiments of asingle-insertion, multiple sample biopsy device. The present inventionalso provides for exemplary embodiments of a single-insertion, multiplesampling device with integrated marker release.

In one aspect, a single-insertion, multiple sample biopsy device isprovided that includes a stylet, a cannula, a plurality of lumensincluding flexible and rigid portions, first and second bulkheads, and atransport subassembly. The stylet extends along a longitudinal axisbetween a distal end and a proximal end, the stylet having a tip at thedistal end and a hollow interior volume extending from a biopsy portproximate the distal end to the proximal end. The cannula surrounds aportion of the stylet and is movable along the longitudinal axis. Theplurality of lumens is disposed in the interior volume. The rigid lumenis coupled to one of the plurality of lumens. The first bulkhead isdisposed near the proximal end. The first bulkhead is coupled to thelumens and a second bulkhead disposed near the distal end. The secondbulkhead is coupled to the rigid lumen, and both bulkheads define abiopsy sample volume. The transport subassembly is coupled to the firstand second bulkheads to move a biopsy sample from the biopsy port to theproximal end of the stylet.

In yet another aspect, a single-insertion, multiple sample biopsy deviceis provided that includes a stylet, cannula, sleeve, lumen, bulkhead andtransport subassembly. The stylet extends along a longitudinal axisbetween a distal end and a proximal end. The stylet has a tip at thedistal end and a hollow interior volume that extends from a biopsy portproximate the distal end to the proximal end. The cannula surrounds aportion of the stylet and is movable along the longitudinal axis. Thesleeve is disposed between the stylet and the cannula. The lumen isdisposed in the interior volume of the stylet. The bulkhead is coupledto a distal end of the lumen. The transport subassembly is coupled tothe lumen and the sleeve to move the bulkhead and sleeve relative toeach other along the longitudinal axis between the proximal and distalends. Preferably, at least a portion of the lumen is flexible.

In yet a further aspect, a method of sampling biological tissue with abiopsy device is provided. The device has a tissue trough coupled to atleast one lumen disposed in a needle that extends along a longitudinalaxis between a distal end and a proximal end. The method can be achievedby: capturing a biological sample in longitudinal aperture defined on acircumference of the needle; and translating said at least one lumenthrough the interior of the needle to transport the biological samplefrom the distal to the proximal ends.

According to an embodiment, the invention is a single-insertion,multiple sample biopsy device with a stylet extending along alongitudinal axis between a distal end and a proximal end. The styletcan have a tip at the distal end and a hollow interior volume extendingfrom a biopsy port proximate the distal end to the proximal end. Acannula surrounds a portion of the stylet and is movable along thelongitudinal axis. There are lumens in the interior volume. A firstbulkhead is disposed near the proximal end and coupled to the lumens. Asecond bulkhead is disposed near the distal end and coupled to one ofthe lumens. Both bulkheads defines a biopsy sample volume. A transportsubassembly is coupled to the first and second bulkheads to move abiopsy sample from the biopsy port to the proximal end of the stylet.

The transport subassembly preferably includes one or both of a vacuumand pressurized fluid supply in fluid communication with one of thelumens and a pulley coupled to the bulkheads and lumens to move thebulkheads and lumens along the longitudinal axis as a single unit. Thefirst bulkhead is preferably configured to confront the interior surfaceof the stylet and the second bulkhead preferably is configured to permitfluid flow between the outer perimeter of the bulkhead and the interiorsurface of the stylet.

According to another embodiment, the invention is a single-insertion,multiple sample biopsy device that includes a stylet extending along alongitudinal axis between a distal end and a proximal end. The stylethas a tip at the distal end. A hollow interior volume extends from abiopsy port proximate the distal end to the proximal end. A cannulasurrounds a portion of the stylet and is movable along the longitudinalaxis. A sleeve is disposed between the stylet and the cannula. A lumenis disposed in the interior volume of the stylet. A bulkhead is coupledto a distal end of the lumen. A transport subassembly is coupled to thelumen and the sleeve to move the bulkhead and sleeve relative to eachother along the longitudinal axis between the proximal and distal ends.

Preferably, the transport subassembly includes a first pulley coupled tothe sleeve via a member and a second pulley coupled to the bulkhead viathe lumen. Also, preferably, the member is in fluid communication with apressurized saline source and the lumen is in fluid communication withone or more of a vacuum and pressurized fluid source. The stylet tip canhave a marker one of the tip and a bulkhead disposed in the stylet. Themarker is ejected from at least one of the tip and the bulkhead in anoperative condition of the device.

Preferably, the stylet tip includes a marker mounted on the outersurface of the tip. The marker is separated from the tip in an operativecondition of the device. The marker is one or more of a hooked marker,helical marker and serrated edge marker. The marker can also be anannular marker or a split-ring marker.

According to another embodiment, the invention is a method of samplingbiological tissue with a biopsy device that has a tissue trough coupledto at least one lumen disposed in a needle that extends along alongitudinal axis between a distal end and a proximal end. The methodcan be achieved by: capturing a biological sample in longitudinalaperture defined on a circumference of the needle; translating the atleast one lumen through the interior of the needle to transport thebiological sample from the distal to the proximal ends. The translatingincludes filling the trough defined by the interior surface of theneedle is disposed about a sliding bulkhead with a bio compatible fluid.

According to another embodiment, the invention is a biopsy device with astylet that extends along a longitudinal axis between a distal end and aproximal end. The stylet has a sample opening and an interior volumeadjacent its distal end, the opening providing access to the interiorvolume. A longitudinal cutting member with a cutting edge is movablewith respect to the stylet such that the cutting edge can cross over thesample opening to cut a tissue sample from a host. At least one lumeninside the stylet and movable along the longitudinal axis has a distalbulkhead at a distal end of the interior volume. A transport subassemblycoupled to the at least one bulkhead moves a tissue sample from thesample port to the proximal end of the stylet. There is a proximalbulkhead at a proximal end of the interior volume. The transportsubassembly includes a motor-drivable pulley with the at least one lumenwrapping at least partly around the motor-drivable pulley. A saline pumpis connected to the at least one lumen which has an outlet incommunication with the interior volume.

According to an embodiment, the invention is a single-insertion,multiple sample biopsy device with a stylet extending along alongitudinal axis between a distal end and a proximal end. The stylethas a tip at the distal end and a hollow interior volume extending froma biopsy port proximate the distal end to the proximal end. A cannulasurrounds a portion of the stylet and is movable along the longitudinalaxis. A plurality of lumens are located in the interior volume. A firstbulkhead is located near the proximal end. The first bulkhead is coupledto the lumens. A second bulkhead is located near the distal end. Thesecond bulkhead is coupled to the one of the lumens. Both bulkheadsdefine a biopsy sample volume. A transport subassembly is coupled to thefirst and second bulkheads to move a biopsy sample from the biopsy portto the proximal end of the stylet.

Preferably, the transport subassembly includes one or both of vacuum andpressurized fluid supply in fluid communication with one of the lumensand a pulley coupled to the bulkheads and lumens to move the bulkheadsand lumens along the longitudinal axis as a single unit. Also,preferably, the first bulkhead is configured to confront the interiorsurface of the stylet and the second bulkhead is configured to permitfluid flow between the outer perimeter of the bulkhead and the interiorsurface of the stylet.

According to another embodiment, the invention is single-insertion,multiple sample biopsy device that includes a stylet extending along alongitudinal axis between a distal end and a proximal end. The stylethas a tip at the distal end and a hollow interior volume extending froma biopsy port proximate the distal end to the proximal end. A cannulasurrounds a portion of the stylet and movable along the longitudinalaxis. A sleeve is located between the stylet and the cannula and a lumenis located in the interior volume of the stylet. A bulkhead is coupledto a distal end of the lumen. A transport subassembly is coupled to thelumen and the sleeve to move the bulkhead and sleeve relative to eachother along the longitudinal axis between the proximal and distal ends.

Preferably, the transport subassembly includes a first pulley coupled tothe sleeve via a member and a second pulley coupled to the bulkhead viathe lumen. The member can be in fluid communication with a pressurizedsaline source and the lumen is in fluid communication with one or moreof a vacuum and pressurized fluid source. Preferably, also, the stylettip includes a marker located in one of the tip and a bulkhead locatedin the stylet. The marker is ejected from at least one of the tip andthe bulkhead in an operative condition of the device.

In a variation, the stylet tip includes a marker mounted on the outersurface of the tip, the marker is separated from the tip in an operativecondition of the device. The marker can be one or more of a hookedmarker, helical marker and serrated edge marker. The marker can be anannular marker or a split-ring marker.

According to another embodiment, the invention is a method of samplingbiological tissue with a biopsy device that has a tissue trough coupledto at least one lumen located in a needle that extends along alongitudinal axis between a distal end and a proximal end. The methodcan be achieved by capturing a biological sample in longitudinalaperture defined on a circumference of the needle and translating the atleast one lumen through the interior of the needle to transport thebiological sample from the distal to the proximal ends. Preferably themethod is such that translating is done by filling the trough defined bythe interior surface of the needle located about a sliding bulkhead witha bio compatible fluid.

According to an embodiment, the invention is a biopsy device with astylet extending along a longitudinal axis between a distal end and aproximal end. The stylet has a sample opening and an interior volumeadjacent its distal end, the opening providing access to the interiorvolume. A longitudinal cutting member has a cutting edge and is movablewith respect to the stylet such that the cutting edge can cross over thesample opening to cut a tissue sample from a host. There is at least onelumen inside the stylet and movable along the longitudinal axis. Thelumen has a distal bulkhead at a distal end of the interior volume. Atransport subassembly is coupled to the at least one bulkhead to move atissue sample from the sample port to the proximal end of the stylet.Preferably, a proximal bulkhead is located at a proximal end of theinterior volume. The transport subassembly includes a motor-drivablepulley, the at least one lumen wrapping at least partly around themotor-drivable pulley. A saline pump is preferably connected to the atleast one lumen, the lumen having an outlet in communication with theinterior volume.

According to an embodiment, the invention is a single-insertion,multiple sample biopsy device, with a cannula forming at least part ofan insertable biopsy needle. The cannula has a distal end where samplesare received and a proximal end where samples are recovered. A shuttlemechanism, includes a distal bulkhead within the cannula. The distalbulkhead is connected to a fluid line. A mechanism feeds and retractsincremental portions of the fluid line. The fluid line is sufficientlystiff, as well as supported by the cannula, to allow the distal bulkheadto be pushed through the cannula, thereby to advance and withdraw thedistal bulkhead within the cannula, whereby samples placed on a proximalside of the distal bulkhead are urged in a proximal direction by thedistal bulkhead.

Preferably, the fluid line is connected to a vacuum pump at its proximalend. Preferably, the fluid line is connected to a saline pump at itsproximal end. A proximal bulkhead is preferably located proximally ofthe distal bulkhead and connected attached to the fluid line. A vacuumline opens to a distal side of the proximal bulkhead. The fluid lineopens to a distal side of the distal bulkhead. The distal bulkhead hasat least one opening permitting flow from its distal side to flowbackward toward its proximal side.

Preferably, there is a sample receiving chamber located at the proximalend. The receiving chamber is preferably adapted to receive and separatemultiple samples, by employing such as a carousel configuration wheresamples drop into recesses and the chamber is rotated. An intermediatesheath is preferably provided in the cannula. The fluid line isconnected to the distal bulkhead by a manifold that fluidly couples thefluid line to an annular space between the cannula and intermediatesheath.

According to an embodiment, the invention is a method of samplingbiological tissue with a biopsy device that has a cutting sheathsurrounding an intermediate sheath which surrounds a cannula. Thecannula has a distal end with a port where tissue samples are receivedand a proximal end where samples are delivered. The cannula carries amovable bulkhead within it. The bulkhead is connected to a suction tube.An annular space is defined between the intermediate sheath and thecannula. The method of employing this apparatus includes: drawing avacuum in the suction tube to suck a sample into the cannula distal endwhile the bulkhead is in a distal position in the cannula and moving thebulkhead proximally while fluid is forced through the annular spacetoward the cannula distal end and back through the cannula to transportthe resected sample to the proximal end. Preferably the method includescovering the sample with the intermediate sheath. Preferably the methodincludes moving the intermediate sheath progressively with the sample.Preferably the method includes moving the bulkhead progressively withthe intermediate sheath and the sample. Also, preferably, the methodincludes holding the intermediate sheath in a retracted positionproximal of the port while drawing the vacuum and extending the cuttingsheath by extending the cutting sheath over the port. The intermediatesheath is then extended over the port to cover the severed sample partlyand the bulkhead retracted while pumping fluid distally through theannular space and proximally through the cannula to transport thesample.

According to an embodiment, the invention is a single-insertion,multiple sample biopsy device with a cutting sheath, an intermediatesheath, and a cannula all is coaxially aligned with the cutting sheathsurrounding the intermediate sheath and the intermediate sheathsurrounding the cannula. An annular space is defined between theintermediate sheath and the cannula. The cannula has a distal end with aport where tissue samples are received and a proximal end where samplesare delivered. The intermediate sheath is movable relative to thecannula to selectively open and close the port. The cannula carries amovable bulkhead within it, the bulkhead being connected to a suctiontube. A drive mechanism forces the tube along the cannula to move thebulkhead distally and proximally. A fluid pumping mechanism pumps fluidinto the annular space when the intermediate sheath partly covers theport, thereby causing fluid to enter the port at a distal end thereofand flow along the cannula in a proximal direction.

Preferably, the drive mechanism and fluid pumping mechanism are operablein concert to move the intermediate sheath to partly cover the port, tomove the bulkhead proximally, and to convey fluid along the annularspace to the port thereby forcing a sample toward the proximaldirection. Also, preferably, the biopsy device includes a vacuum pumpconnected to the suction tube.

According to another embodiment, the invention is a biopsy device with astylet that has a sample extraction portion and a sample recoveryposition. A first bulkhead engages with, and is movable along, thestylet. A drive member attaches to the first bulkhead to move the firstbulkhead between the sample extraction portion and the sample recoveryposition. A fluid conveyance conveys fluid into the stylet as the firstbulkhead is moved from a position distal of the sample extractionportion to the sample recovery position sufficient to lubricate a tissuesample engaged by the first bulkhead as it the sample is moved along thestylet.

Preferably, the fluid conveyance generates a flow of fluid at a rate,the rate being lower than a rate required to force a tissue sample alongthe stylet by hydraulic pressure. Also, preferably, the drive memberincludes a lumen running along the stylet, the lumen forming a portionof the fluid conveyance. Also preferably, the fluid conveyance includesa lumen within the drive member. Also preferably, the device includes africtional drive member that engages the drive member and moves it alongthe stylet. In another embodiment, the second bulkhead attaches to thedrive member and is located proximal of the first bulkhead, the firstand second bulkheads defining a sample recess between them.

According to yet another embodiment, a biopsy device has a stylet havinga sample extraction portion and a sample recovery position. A drivemember is movable between the sample extraction portion and the samplerecovery position. A fluid conveyance conveys fluid into the stylet asthe drive member is moved from a position distal of the sampleextraction portion to the sample recovery position sufficient tolubricate a tissue sample engaged by the first bulkhead as it the sampleis moved along the stylet. Preferably, the fluid conveyance generates aflow of fluid at a rate, the rate being lower than a rate required toforce a tissue sample along the stylet by hydraulic pressure. Also, thedrive member preferably includes a lumen running along the stylet, thelumen forming a portion of the fluid conveyance. Preferably, the fluidconveyance includes a lumen within the drive member. More preferably, africtional drive member engages the drive member and moves it along thestylet.

According to yet another embodiment, a biopsy device has a stylet havinga sample extraction portion and a sample recovery position. A drivemember is movable between the sample extraction portion and the samplerecovery position. A fluid conveyance conveys fluid into the stylet asthe drive member is moved from a position distal of the sampleextraction portion to the sample recovery position sufficient to fill anexpanding space remaining distal of the drive member as the drive membermoves from the sample extraction portion to the sample recoveryposition. Preferably, the fluid conveyance generates a flow of fluid ata rate, the rate being lower than a rate required to force a tissuesample along the stylet by hydraulic pressure. Also, the drive memberpreferably includes a lumen running along the stylet, the lumen forminga portion of the fluid conveyance. Preferably, the fluid conveyanceincludes a lumen within the drive member. More preferably, a frictionaldrive member engages the drive member and moves it along the stylet.

In the above-described embodiments, a vacuum source and a power sourcecan be provided in a self-contained hand-held biopsy device. In all ofthe methods, a biopsy unit can contain a controller programmed toexecute the methods automatically or contingent on consecutive commandbeing entered through the biopsy device.

In the above-described embodiments, the one or more lumens extendingthrough the needle (e.g., the stylet) can be, and preferably are, rigidalong their length within the needle and flexible only along portionsthat are required to bend. This ensures that the lumens can be used topush the corresponding transport members (e.g., bulkhead(s)) formultiple sampling. In this case, flexible is intended to encompasspiece-wise flexible (i.e., a combination of rigid portions linked byflexible or hinged joints) such as fluid conveyances that are made upwith multiple hinged elements as links in a chain. There are known andcommercially available devices that flex but provide fluid-tight flowchannels.

In addition, the rigidity of the lumens can be derived from a secondaryelement that houses the lumen to give it rigidity, meaning a rigidportion of a lumen does not need to be a monolithic structure and theuses of terms such as “rigid lumen” or “rigid portion of a lumen” arenot intended to limit the identified lumen structures to single-elementstructures. For example, a flexible lumen can be guided by a rigidmember (for example it can slide within a tube) giving it all theeffective rigidity needed to enable the lumen to move a transport memberdistally within a needle. Or a flexible tube can have a moving rigidguide (tube or other structure) to which it is fixedly attached, to giveit all the effective rigidity needed to enable the lumen to move atransport member distally within a needle.

In addition, also in the above-described embodiments, instead of windingthe proximal end or ends of the lumen or lumens around a pulley, thelumens can be folded, accordion-fashion at their proximal ends and adrive employed to move the lumens along the needle (e.g., the stylet).The drive can be a pair of opposing rotating drive wheels that pressagainst the proximal portion of the lumen (or a member attached to thelumen) and frictionally engage a portion of the lumen or a structureattached to it to drive the lumen along the stylet. Alternatively acapstan drive could be used with the lumens winding partially around it.

While in most of the embodiments described, a pair of lumens aredescribed, one for vacuum and one for fluid, a single lumen providingvacuum at one time and fluid at another time could be employed. Aswitching mechanism provided at the proximal end could allow thisalternative. In this case, the drive mechanism for the bulkheads wouldfunction as described with a single lumen running along the styletrather than two.

Although in most of the disclosed embodiments, fluid is provided to thedistal end of the needle and permitted to flow proximally as the tissuesample is transported proximally, the fluid itself need not, and inembodiments, preferably is not, sufficient in quantity or velocity tomove the tissue sample. That is, preferably, the fluid rate does notproduce enough drag on the sample, given the seal between the sample andthe stylet, the fluid flow rate, and the hydrodynamic properties of thesample, to transport the sample along the stylet. The fluid ispreferably provided to flood the sample chamber and lubricate thepassageway for transport. In addition the fluid may be only sufficientto fill in the space behind the bulkhead or bulkheads so that they, andthe tissue, move more freely without creating any vacuum, evenmomentarily, in their wake. Preferably, the bulkheads described in thedisclosed embodiments to not form a seal with the stylet or cannula. Inthis way fluid can flow around them easily. In fact, the fluid used tolubricate movement of the bulkhead(s) and sample may be provided at themiddle of the sample chamber or proximal of the sample chamber andallowed to flow around the bulkheads to aid in transporting andpreventing a vacuum.

In addition to the transport function, the fluid also provides acleaning function; clearing bits of tissue sample or aspirated materialfrom the host from the stylet. In an embodiment that is a self-containedhandheld, as is the preferred embodiment, the quantity of fluid shouldbe minimal, but in other embodiments where large amounts of fluid can beprovided, the fluid flush can be substantial and continue for a longinterval after the sample is received at the recovery location.

Although in most of the disclosed embodiments, the transport mechanismrelies on the lumen or lumens themselves to transport the bulkheads, thefluid carrying and bulkhead-transporting functions can be performed byseparate elements.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate presently preferred exemplaryembodiments of the invention, and, together with the general descriptiongiven above and the detailed description given below, serve to explainfeatures of the invention.

FIG. 1 illustrates a perspective view of a biopsy device and transportsubassembly according to one exemplary embodiment of the presentinvention.

FIG. 1A illustrates an exemplary embodiment of ancillary components forthe biopsy cutter and transport assembly of FIG. 1.

FIG. 1B1 illustrates the distal end of the biopsy device embodiment ofFIG. 1 with the cutting cannula retracted.

FIG. 1C1 illustrates a cut-away view of FIG. 1A with the cutting cannulaand stylet removed for clarity.

FIGS. 1D and 1E are a close-up view of a distal end of the transportmechanism of FIG. 1A and other embodiments.

FIG. 1C1 illustrates the mechanism of FIG. 1B with the cutting cannulaor cutter fully advanced.

FIGS. 1B2, 1C2, 1F2, 1F1, 1G, and 1H illustrate a sequence operations ofa biopsy tissue extraction device.

FIG. 2A illustrates another preferred embodiment of a biopsy needle andtransport elements.

FIG. 2B illustrates a cut-away view of the device of FIG. 2A with thecutting cannula or cutter retracted.

FIG. 2C is a view of the device of FIG. 2B showing cutting cannula.

FIGS. 2D-2H illustrate a sequence of biopsy tissue extraction operationsusing the device of FIG. 2A.

FIGS. 2I-2N illustrate saline pumping and recovery plumbing componentswhich may be used for tissue transport and other operations such asvacuum suction.

FIGS. 3A-3C and 3E-3G illustrate an integrated biopsy marker system foreach of the devices of FIGS. 1A and 2A.

FIG. 3D illustrates various markers usable with the system of FIG. 3A.

FIGS. 4A-4D illustrate another integrated biopsy marker system for eachof the devices of FIGS. 1A and 2A.

FIGS. 5A1, 5A2, 5A3, 5B, and 5C illustrate a further integrated biopsymarker system for each of the devices of FIGS. 1A and 2A.

FIGS. 6A and 6B illustrate yet another integrated biopsy marker systemfor each of the devices of FIGS. 1A and 2A.

FIGS. 7A, 7B, 8A, and 8B illustrate various components of an embodimentof a biopsy device with particular emphasis on the drive mechanism, thedevice having a disposable part and a durable part which mate to createan operable device.

FIG. 9 illustrates an alternative lumen and drive arrangement applicableto most of the embodiments.

FIG. 10 illustrates an alternative another lumen and drive arrangementapplicable to most of the embodiments.

FIG. 11 illustrates a controller.

DETAILED DESCRIPTION OF THE PREFERRED EXEMPLARY EMBODIMENTS

FIGS. 1-6 illustrate the preferred exemplary embodiments. In particular,FIG. 1 shows a perspective view of a stylet 10 coupled to thesingle-insertion, multiple samples biopsy device 100 provided with atransport subassembly 200A. The transport subassembly 200A includes thestylet, which has a tip 11 at the distal end and an outer cuttingcannula 20 covering a substantial portion of the stylet 10 and a firstport 10A. Extending through a hollow portion of the stylet 10 are twoflexible lumens 12 and 14 coupled to a common pulley 16 proximate asecond port 10B. The transport subassembly 200A can be coupled toancillary components of the device 100 such as respective saline 37reservoir and pump and vacuum and air pressure pump 39, a motor drive200A, and switches and sensors as shown in FIG. 1A.

Referring to FIG. 1D, the flexible lumens 12 and 14 are coupled to afirst bulkhead 18. A second bulkhead 22 is coupled to the first bulkheadvia a rigid lumen 24. One of the flexible lumens 12 and 14 can be influid communication with a pressurized or negative pressure (i.e.,vacuum) source. The other of the flexible lumens 12 and 14 can be influid communication with a bio-compatible fluid such as, for example,saline. In the illustrated embodiment, preferably lumen 14, which isfluidly continuous with lumen 24, carries liquid, such as saline and thelumen 12, which opens on the distal side of the first bulkhead 18,carries air under either positive pressure or vacuum.

The first bulkhead 18 can be configured to be disposed in the hollowstylet 10 in the manner of a piston loosely reciprocating in a cylinderarrangement. To avoid a pressure being generated, the first bulkhead andthe stylet 10 can be configured such that they do not form a sealbetween them, for example, by sizing the first bulkhead 18 accordinglyor by providing ports through it. To allow fluid flow between the secondbulkhead 22 a bulkhead, similar in structure to the first bulkhead 18 isused, except that grooves 22B are provided (for example by machining ormolding) on the outside surface of the bulkhead 22. These grooves 22Ballow fluid to pass in a proximal direction into the first port 10A fromthe distal side of the second bulkhead 22 after being conveyed therethrough lumen 24. Alternatively, a through-opening 22C can be providedfor the second bulkhead 22 instead of, or in addition to, the grooves22B to provide a similar effect. Preferably, the lumens 12 and 14 aresufficiently flexible to allow them partly wound about a pulley 16 (See,for example, FIG. 1G) and that the rigid lumen may be, and preferablyis, rigid.

Referring to FIGS. 1B1 and 1B2, the outer cutting cannula 20 is shown ina retracted position. This is preferably done after inserting the tipportion TP in a host where a tissue sample BSM is be excised andrecovered. The retracted cannula 20 exposes the first port 10A formed bythe hollow portion of the stylet 10. A sample of the biological tissuecan be captured by providing a vacuum via one of the flexible lumens 12,14; preferably 12 as discussed above, so that biological tissues aredrawn into the first port 10A by the suction. In addition, a user mayapply external pressure to the host to assist in moving tissue into thefirst port 10A.

The first port 10A has an internal volume V defined by the two bulkheads18 and 22 and the inside surface of the cutting cannula 20. For a 14gauge stylet or needle, the internal volume is sufficient to capture amass of at least 50 milligrams of biological tissues, e.g., test tissuessuch as turkey breast tissues. For a 10 gauge stylet 10, the internalvolume is sufficient to capture a mass of at least 150 milligrams ormore of biological tissues. The length of the stylet 10 can be of anysuitable lengths, such as, for example, about 250 to about 300millimeters. The volume V of the housing containing all of thecomponents of the device 100 is preferably about 0.32 cubic centimeterswith particularly preferable dimensions of about 40 millimeters by about40 millimeters and about 200 millimeters.

As used herein, the term “about” or “approximately” for any numericalvalues indicates a suitable dimensional tolerance that allows the partor collection of components to function for its intended purpose as abiopsy cutter, biopsy system or the combination of both the system andcutter.

Details of the lumens 12, 14, and 24 are explained with reference toFIGS. 1D and 1E. In FIG. 1D, two flexible lumens 12 and 14 are coupledto a proximal or first bulkhead 18 with one of the flexible lumens 12 or14 being coupled to a rigid lumen 24, which is coupled to a distal orsecond bulkhead 22. Both the proximal bulkhead 18 and the distalbulkhead 22 are configured to allow the flow of saline to be dispersedthrough between the two bulkheads 18 and 22.

Referring back to FIGS. 1B1 and 1C1 (also FIGS. 1B2 and 1C2), once thetissue sample BSM is suctioned into the tissue receiving trough or firstport 10A via the flexible lumen 12, the cannula 20 is advanced toseparate the biological tissue BSM from the larger main mass ofbiological tissue. The cutting action by the cannula 20 can be bytranslation, rotation, translation and rotation or a combination ofthese movements along with back and forth axial movements of the cannula20 as part of the cutting strategy. The cutting cannula 20 can formsomewhat of a seal with the stylet tip 11 at full extension of thecutting cannula 20 along the longitudinal axis A. At this point, thepulley 16 (FIG. 1G) can be used to retract both bulkheads 18 and 22towards the pulley 16 (i.e., proximally). At the same time saline S isdelivered through the saline lumen 24 to enter a gap formed between thedistal bulkhead 22 and the stylet 10. The saline flows back out of thegap through the openings formed by the grooves 22A and/or the port 22Cinto the port 10A, while the bulkheads 18 and 22 are retracted using thepulley 16. The saline wash lubricates the acquired tissue sample BSM(and the moving bulkheads 18 and 22) as the sample is retracted throughthe hollow portion of the stylet 10, as shown in FIGS. 1F1 and 1F2.

Once the tissue sample BSM is transported to the second port 10B, thetissue sample can be expelled into a collection vial or receptacle (notshown) using a suitable ejection mechanism such as, for example, salinesolution S, pressurized fluid P or air a combination of both, as shownin FIG. 1H. To accomplish this, fluid and/or air may be forced throughone or both of lumens 12 and 14.

In the variation shown in FIGS. 2A-2H, an alternative transportsubassembly 200B to transport the tissue sample BSM towards the secondport 10B is provided. Specifically, the mechanism includes a stylet 10surrounded for a portion with a cutting cannula 20 and a sleeve disposedbetween the stylet 10 and the cannula 20. The stylet 10 includes atipped portion 11A and hollowed portion 11B, flexible saline tubing 3428 coupled to an intermediate sleeve 26 via a manifold 32, which iscoupled to a secondary transport pulley 30. The flexible vacuum lumen 12is coupled to a proximal bulkhead 18 at one end and a tissue transportpulley 16 at an intermediate portion of the flexible lumen 12. Referringto FIG. 2B, the stylet tip 11 can be a substantially solid and generallysymmetric cone tip coupled to a hollow elongated portion 11B bounded bythe bulkhead 18, which is connected to the flexible vacuum lumen 12.With the stylet 10 inserted into a host, the cutting cannula 20 andintermediate sleeve 26 are retracted, as shown in FIG. 2C. In thisposition, the first port 10A is exposed to allow a tissue sample BSM tobe drawn into a trough defined by the interior volume of the stylet 10and the bulkhead 18. The tissue sample BSM that can be captured in thefirst port 10A can be substantially the same mass as that of the deviceof FIG. 1A. However, due to the elimination of the distal bulkhead andthe rigid saline lumen, the mass of biological tissues that can becaptured can occupy a greater fraction of a corresponding needle axiallength in this embodiment.

The sequence of operations for tissue transport are illustrated in FIGS.2C-2H. In FIG. 2C, the cutting cannula 20 and intermediate sleeve 26 areretracted proximally to expose the first port 10A while the cannula 20is in the host. Vacuum is applied through the lumen 12, thereby creatinga vacuum in the first port 10A. This draws the tissue sample BSM intothe first port 10A. Then the cutting cannula 20 is extended distally, asshown in FIG. 2D, to sever the tissue sample BSM from the host. Thetissue sample BSM is now contained and ready for transport to the secondport 10B.

Referring to FIG. 2E, the intermediate sleeve 26 is extended distally tocover the first port 10A. Preferably, the first port 10A is only partlycovered so that a gap is provided between the outer surface of theintermediate sleeve 26 and the inner surface of the cannula 20. This gapallows saline fluid to flow through the gap to fill the first port 10Aafter being pumped from the proximal end in the annular space betweenthe outer cannula 20 and the intermediate sleeve 26. The intermediatesleeve 26 is connected at a proximal end to a manifold 32 locatedbetween first and second ports, shown here in FIG. 2F. The manifold 32is coupled to the flexible saline tubing 34, which is coupled to thesecondary transport pulley 30 (indicated by the reference numeral inFIG. 2A and visible in FIG. 2F as well). so that upon rotation of thesecondary transport pulley 30, the manifold 32 is moved distally orproximally. As the manifold 32 is moved, an end cap 32A of theintermediate sleeve 26 is also movable (FIG. 2F) due to a connectionbetween the end cap 32A and the manifold 32. The end cap 32A allows forsaline to flow from the tubing 34 to the manifold 32 and through the gapbetween the cutting cannula 20 and the sleeve 26 towards the first port10A (FIG. 2E) to provide lubrication for the moving lumen, provide apreservative, and provide a liquid flush for any loose remnants oftissue samples. The tissue BSM can be ejected into the collectionchamber 36 by at least the saline S flowing through the hollow stylet.Alternatively, pressurized fluid or liquid can be provided via the lumen12 to eject the tissue sample, alone or in combination with the salineS. The rate of saline flowing can be, and preferably is, increased forejection purposes over the rate used to transport the tissue sample BSM.

Although only one tissue collection chamber 36 is shown, the chamber 36can be a plurality of chambers disposed about the stylet 10 in a radialpattern so that the chambers can be rotated to accept tissue sampleseach time the transport 200A or 200B is activated to transport a sampleto the second port 10B. The vacuum source can be used to remove excessfluid from the stylet 10/sheath 26 assembly after the sample BSM isejected. The vacuum may also help to aspirate fluid from the host thatwas drawn into the stylet 10/sheath 26 assembly.

In an alternative embodiment, the intermediate sleeve 26 can be omittedand fluid may be pumped between the outer cannula 20 and the stylet 10.In this embodiment, the stylet 10 fits into the outer cannula 20 with aclose spacing, preferably with a spacing (difference between styletouter diameter and outer cannula inner diameter) between 1 and 6thousandths of an inch and more preferably with a spacing between 1 and3 thousandths of an inch. In this case, fluid may not be conveyed to thedistal end of the sample recess 10A, but will still be effective,particular in small gage needles, for example 14 gage needles, toadequately facilitate transport of the sample.

FIGS. 2I-2N describe a saline pumping mechanism that may be used withthe above and other embodiments. In FIG. 2I, a dual-action pump 40(e.g., a syringe actuatable by a drive motor) can be used to generatenegative pressure by forcing a piston 46 to expand the volume of achamber 40A, which is in communication with the main passage 10F of thestylet 10. A four-way valve 44, with a vent 42 at one branch, isconfigured to empty the chamber 45 to the ambient through the four-wayvalve and out the air vent 42 as air is sucked into the chamber 40A.Note that the vent 42 may be fitted with a filter to preventcontamination leaking into the biopsy device.

The vacuuming action draws in a tissue sample 53. To trigger the cuttingof the sample, sensors (not shown) may be used to detect the movement ofthe tissue sample 53 into the lumen 10G, or the passage of an elapsedtime interval or user action may be used to determine that a sample 53has been drawn into the passage 10G. The outer cannula 20 can be used tosever the tissue sample from the host. Alternatively, a cannula disposedinternally of the stylet 10 can also be used.

At this point, shown here in FIG. 2J, the four-way valve 44, with a vent42 at one branch, is configured to allow the dual-action pump 40 to drawsaline into port 40B. With the outer cannula 20 covering the port 10A(not shown for clarity), the dual-action pump 40, via the four-way valve44, forces saline to flow through passage 10B, causing the tissue sampleto be transported proximally towards through-port 10B (e.g., FIGS. 1,2A). As the sample encounters the mesh material 39B in a collection vialor cartridge, it remains in place while residual saline falls into thesump 55. Any remaining saline in the lumens can be drawn back into thereservoir 48 by first drawing from the lumens into the chamber 45 (FIG.2L) and then pumping into the reservoir 48 (FIG. 2M) for subsequent useby the dual-action pump 40.

Referring to FIG. 2N, in an alternative embodiment, the passage 10F isprovided with a flexible tube segment 10R that can be pinch-clamped bymeans of a valve actuator 10S. In this configuration, a pair of inlineconnectors 10V and 10W provides a smooth transition from a lead in part10P to a lead out part 10Q to allow fluid and samples to pass through asin the earlier embodiment of passage 10F. The reason for adding thiscapability to close the valve is to allow a stronger vacuum to bedeveloped in the sample area 10A by improving the volumetric efficiencyof the dual action pump 40. To apply a vacuum to sample port 10A, thepiston valve is configured to draw from the lumen 10B. The clamp 10S isclosed. The piston 46 is moved to the right to generate the vacuum byexpanding the volume of chamber 45. Because the passage 10P is closed,the total volume evacuated, relative to the chamber volume 45, ismarkedly decreased. This configuration of passage 10P also has theadvantage of avoiding the need for vacuum-competent sealing of thecollection chamber 56 and sump 55.

The examples shown in the illustrations and described in detail abovecan be integrated with one or more of four exemplary marking systems. Inparticular, each of four marking systems can be integrated with each ofthe two examples described to provide for eight different integratedbiopsy cutter and marker systems. For clarity, only the four markingsystems will be described and shown below. However, those skilled in theart can combine each marker system with each of the biopsy cuttersystems as appropriate to arrive at a suitable permutation of biopsysampling device and integrated marker.

Referring to FIGS. 3A-3G, a marker system utilizing a hook type marker41 (i.e., a “harpoon”) to prevent migration of the marker 41 once it hasbeen deployed, is shown. The hook type marker 41 can be deployed insequence or simultaneously with the sampling of biopsy tissues with thevarious technologies described in relation to FIGS. 1 and 2 above. Asshown in FIGS. 3A and 3E, a rod (e.g., an internal D-Rod 20A or thecutting cannula 20) can be used to eject a marker 41 stored in thestylet tip 11. In the exemplary embodiment of FIGS. 3A-3G, a rod 20A isprovided with a cut-out portion 20B having a ramp 20C formed on a distalend of the rod 20A. The ramp 20C can be used (depending on whether thecannula 20 or rod 20A is axially translated only, rotated only or acombination of axial translation and rotation) to ensure that the marker41 is deposited sufficiently near the tissue sampling site. Variousmarker configurations can be utilized. For example, marker with wirelike hooks 41A, square sectioned hook 41B, or marker with serrated edges41C can be used in this system. Alternatively, the first and secondbulkheads 18 and 22 (FIG. 1B2) can be provided with a recess for storageof a marker 41 so that upon actuation of the inner cannula 20A, a firstmarker can be released from the first bulkhead 18, a second marker fromsecond bulkhead 22, and a third marker 41 can be released from the tip11 upon actuation of an internal cannula 20A (FIG. 3A) to close port10A.

Referring FIGS. 4A-4D, a marker system utilizing a split ring marker 42can be utilized with various biopsy techniques described above inrelation to FIGS. 1 and 2. In FIG. 4A, the split-ring marker 42 can bemounted to the stylet 10 via a suitable technique such as, for example,crimping, swaging or semi-permanent bonding. Optionally, an intermediatemember 38 that forms a seal with the cannula or cutter 20 can beprovided to maintain a generally constant outer diameter of the cannula20 without an abrupt transition to the tip 11. The split-ring marker 42can be deployed by itself, simultaneously with the sampling of thetissue, prior to sampling or subsequent to the sampling. As shown inFIG. 4B, the stylet tip 11 can be actuated proximally towards the userto force the split-ring marker 42 to detach from the tip 11.Alternatively, the cutting cannula 20 can be actuated distally away fromthe user to force the split-ring marker 42 to separate from the stylettip 11.

Referring to FIGS. 5A1, 5A2, 5A3, 5B and 5C, a marker system using ablossom-type marker 44 can be utilized with various biopsy techniquesdescribed above in relation to FIGS. 1 and 2. As shown in FIG. 5A, theblossom marker 44 is mounted on a specially configured stylet tip 110(FIG. 5C), which has grooves 112 and ramps 114 disposed about alongitudinal axis of the tip 110. The blossom marker 44 can be mountedby a suitable technique, such as, for example, crimping, swaging, orcasting onto the specially configured stylet tip 110. As shown in FIG.5B, the cutting cannula 20 can be moved distally away from the user toforce the blossom marker to be separated from the stylet tip 11. As themarker 44 is separated from the tip 110, the ramps 114 on the tip 110force the sectioned tips 44A to blossom, thereby forming hooks 44A.Alternatively, the stylet tip 11 can be actuated proximally towards theuser so that the marker is deployed via contact against the cuttingcannula 20.

Referring to FIGS. 6A and 6B, another marker system is shown which usesa spiral-type marker 46 in conjunction with various biopsy systemsdescribed above in relation to FIGS. 1 and 2. As shown in FIG. 6A, acoiled marker wire 46 can be disposed in a hollow proximal section 111of the stylet tip 11. A suitable deployment mechanism can be used toeject the coiled marker wire out of its storage space in the stylet tip11. The deployment mechanism can be a suitable mechanism, such as, forexample, a linear-to-rotary motion converter that converts a linearmotion into a rotary motion to rotatably expel the marker.

The materials suitable for use as part of each marker can be, forexample, stainless steel, gold, titanium, platinum, tantalum, bariumsulfate, biodegradable iron or shape memory polymer or metal alloy suchas Nitinol. It is noted that Nitinol is radio-opaque, ultrasonicallyopaque and MRI compatible and therefore would be preferred by itself orin combination with other materials described herein and as known tothose skilled in the art. Further, the markers can be of any suitablesize so that it can be fitted onto a 7, 8, 9, 10, 11, 12, 14, or 16gauge needle.

Although the markers have been shown as a single deployment marker, someof the embodiments disclosed herein can be utilized in a multipledeployment aspect. For example, the tip 11 can be configured to store aplurality of harpoon markers 41; the stylet 10 can be mounted with alongitudinal series of split-ring markers 42; the tip 11 can beconfigured with a cutter so that multiple helical markers can bedeployed.

Referring to FIGS. 7A, 7B, 8A and 8B, a disposable component 251 mateswith a durable component 250 to form a biopsy device 201. The disposablecomponent carries an cutting cannula 220, which functions as the cuttingcannula 20, described above, for example with reference to FIGS. 1B1 to1H. The cutting cannula 220 is moved along its axis in distal andproximal directions by a worm gear 266 that threads with a nut 274mounted in a disposable chassis 268. When the disposable chassis 268 ismounted in the durable component 250, a gear 256 meshes with a pinion270 of a cutter drive 290 housed in the durable component 250. The wormgear 266, which is connected to the gear 256 is thus rotated by thecutter drive 290 advancing and retracting the cutting cannula 220.

The disposable chassis 268 may be connected to further elements (notshown) to support a pulley 216, a motor 288 that drives the pulley 216,and an encoder 280 that is used to control the position of the pulley216. The additional elements carried with the disposable chassis 268 mayinclude fluid and vacuum circuit 260. The durable component 250 maycarry various motor drives including the drive 290, a pulley drive 292and a peristaltic pump 284.

In the present embodiment, the pulley 216 is a component of the pulleydrive 290. Its functions are essentially the same as for the pulley 16described above, for example with reference to FIG. 1. In the presentembodiment, bulkheads 218 and 222, rigid lumen 224, flexible lumens 212and 214, a sampling port 210A, a recovery port 210B, and a stylet 210with a tip 211 all function as the bulkheads 18 and 22, rigid lumen 24,flexible lumens 12 and 14, sampling port 10A, recovery port 10B, and thestylet 10 with tip 11 described above. A sample chamber 258 may beprovided at the recovery port 210B to capture and protect the sampleonce ejected from the recovery port 210B.

A slack extension 276 of flexible lumens 212 and 214 is stored in anenclosure 252 which allows the slack extension 276 to unroll and wind upas the flexible lumens 212 and 214 are extended and withdrawn by thepulley 216. The slack extension 276 is shown as it would appear when theslack is used up by extending the lumens as well as as it would appearwhen the slack is stored by retracting the lumens. So though two loopsare shown at 276, it is only actually one loop shown in both theextended and retracted positions. An encoder 280 is used to control theposition of the bulkheads 218 and 222 within the cutting cannula 220.The pulley 216 may be driven by a motor 288 affixed to the durablecomponent 250.

A guide tube 278 holds the flexible lumens 212 and 214 as they are movedalong the axis of the cutting cannula 220. The flexible lumens 212 and214 may be relatively stiff along lengths that do not need to be greatlystrained during the movement of the bulkheads 218 and 222. For examplethe portions of the flexible lumens 212 and 214 that run through guidetubes 278 and cutting cannula 220 may be relatively stiff compared tothe portions that wrap around the pulley 216. Preferably the flexibletubes 212 and 214 are inelastic in tensile and compression modes. Also,preferably, the stiffness and inelasticity are such that the tissueshuttle can be moved through the biopsy needle in a predictable andrepeatable way by pulling and pushing the lumens 212, 214.

Within the guide tube 278 and cutting cannula 220, there may be one ormore bulkheads 242 to help maintain a straight trajectory of theflexible lumens 212 and 214. The spacing may be determined according tothe flexibility of the flexible lumens 212 and 214 to ensure that themovement of the bulkheads 212 and 214 is predictable and consistent,thereby enabling control of the latter by means of the encoder 280located on the pulley 216. A gap between the end of the cutting cannula220 and the guide tube 278 gives the cutting cannula 220 room to moveover its axial range.

A controller (not shown) may be configured to control the drives 288 and290 such that the following operation sequence can be realized to obtaina sample and deliver the sample to the port 210B. The procedure may beas follows.

-   -   1. Upon insertion of the disposable component 251, assert a home        position in which the cutting cannula 220 and the flexible tubes        212 and 214, along with the connected bulkheads 222 and 218, are        fully extended toward the distal end. This may be done by        running drives 288 and 290 to registration positions, where        respective (limit) switches triggered, and counting the pulses        of respective encoders. The indication of insertion may be by        means of switch (not shown) on the durable component 250        triggered by a boss (not shown) on the disposable chassis 268.        The registration may be followed by the retraction of the        chassis 268 in preparation for a thrusting operation as is known        for biopsy needles.    -   2. Upon receipt of a command (e.g., a control panel switch) to        obtain a sample, a vacuum pump (not shown, but preferably a        component such as a syringe is provided in the disposable        component 251 and a mating drive is provided in the durable        component 250) is operated to obtain an initial vacuum.    -   3. As soon an initial vacuum is generated, the cutting cannula        220 is retracted by running the drive 288 while counting pulses        of the encoder 280 to a proximal stop point. Alternatively        control signaling can be provided by a limit switch.    -   4. After a programmed interval, following the retraction of the        cutting cannula 220, the cutting cannula 220 is driven distally        by operating the motor/transmission drive 290 while counting        pulses of an encoder to a distal stop point. Alternatively        control signaling can be provided by a limit switch.    -   5. The flexible tubes 212 and 214 are retracted by running the        drive 288 to bring the gap between the bulkheads 222 and 218 to        the port 210B while flushing saline in a proximal direction.        This may be done by running the peristaltic pump 284 and        counting pulses of the encoder 280 to a proximal stop point or        according to signals of a limit switch.    -   6. After the sample reaches the port 210B, the sample may be        ejected as described above, for example using a puff of air or        saline or both. The sample may then be housed in the sample        chamber 258 or any of the cartridge embodiments described above.

In the above-described embodiments, the one or more lumens extendingthrough the needle (e.g., the stylet) can be, and preferably are, rigidalong their length within the needle and flexible only along portionsthat are required to bend. This ensures that the lumens can be used topush the corresponding transport members (e.g., bulkhead(s)) formultiple sampling. In this case, “flexible” is intended to encompasspiece-wise flexible such as fluid conveyances that are made up withmultiple hinged elements as links in a chain. There are known andcommercially available devices that flex but provide fluid-tight flowchannels.

In addition, the rigidity of the lumens can be derived from a secondaryelement that houses the lumen to give it rigidity, meaning a rigidportion of a lumen does not need to be a monolithic structure and theuses of terms such as “rigid lumen” or “rigid portion of a lumen” arenot intended to limit the identified lumen structures to single-elementstructures. For example, a flexible lumen can be guided by a rigidmember (for example it can slide within a tube) giving it all theeffective rigidity needed to enable the lumen to move a transport memberdistally within a needle. Or a flexible tube can have a moving rigidguide (tube or other structure) to which it is fixedly attached, to giveit all the effective rigidity needed to enable the lumen to move atransport member distally within a needle.

Referring to FIG. 9, an alternative drive to the above-describedembodiments employs a folding, rather than winding lumen take-upmechanism. Instead of winding the proximal end or ends of the lumen orlumens around a pulley, the lumens 302 can be folded, accordion-fashion306 at their proximal ends and a drive 300 employed to move the lumensalong the needle 310 (e.g., the stylet). The lumen or lumens may beprovided with natural kinks 305 between rigid portions 307 so that itfolds naturally when driven proximally. Only a portion of the lumens 302would need to have the kinks 305. As an example, the drive 300 can be apair of opposing rotating drive wheels 312 that press against theproximal portion of the lumen 302 (or a member attached to the lumen)and frictionally engage a portion of the lumen or a structure attachedto it to drive the lumen 302 along the stylet 310. Alternatively acapstan drive (not shown) could be used with the lumens windingpartially around it. The bulkheads 304 and 305 are thereby moved asdescribed in the other embodiments and in other respects this embodimentconforms to their alternative descriptions.

While in most of the embodiments described, a pair of lumens aredescribed, one for vacuum and one for fluid, a single lumen providingvacuum at one time and fluid at another time could be employed. Aswitching mechanism provided at the proximal end could allow thisalternative. In this case, the drive mechanism for the bulkheads wouldfunction as described with a single lumen running along the styletrather than two.

Although in most of the disclosed embodiments, fluid is provided to thedistal end of the needle and permitted to flow proximally as the tissuesample is transported proximally, the fluid itself need not, and inembodiments, preferably is not, sufficient in quantity or velocity tomove the tissue sample. That is, preferably, the fluid rate does notproduce enough drag on the sample, given the seal between the sample andthe stylet, the fluid flow rate, and the hydrodynamic properties of thesample, to transport the sample along the stylet. The fluid flow rate,in a preferred embodiment where fluid economy is paramount, such as aself-contained handheld device, may preferably provide enough fluid toflood the sample chamber and lubricate the passageway for transport.Further, in addition, the fluid may be only sufficient to fill in thespace behind the bulkhead or bulkheads so that they, and the tissue,move more freely without creating any vacuum, even momentarily, in theirwake. That is, the fluid conveyance would convey fluid into the styletas the sample is moved to fill an expanding space remaining distal ofthe sample and bulkhead as the bulkhead moves proximally.

Preferably, the bulkheads described in the disclosed embodiments to notform a seal with the stylet or cannula. In this way fluid can flowaround them easily. In fact, the fluid used to lubricate movement of thebulkheads) and sample may be provided at the middle of the samplechamber or proximal of the sample chamber and allowed to flow around thebulkheads to aid in transporting and preventing a vacuum.

In addition to the transport function, the fluid also provides acleaning function; clearing bits of tissue sample or aspirated materialfrom the host from the stylet. In an embodiment that is a self-containedhandheld, as is the preferred embodiment, the quantity of fluid shouldbe minimal, but in other embodiments where large amounts of fluid can beprovided, the fluid flush can be substantial and continue for a longinterval after the sample is received at the recovery location.

Although in most of the disclosed embodiments, the transport mechanismrelies on the lumen or lumens themselves to transport the bulkheads, thefluid carrying and bulkhead-transporting functions can be performed byseparate elements. For example, as illustrated in FIG. 10, a stuff butflexible member 334, such as a spring steel band or wire, wraps around atake-up drum 328 which is rotated by a motor (not shown). The lumens 332are flexible and passively move with the bulkhead 304. The flexibletubing fold 335 or even simply coil since it can be highly flexible inthis embodiment.

Referring to FIG. 11, in all of the above embodiments, various motors,drives, valves, and other actuators are variously described along withtheir respective operations and operational sequences. It is clear fromthe particulars of each embodiment that a device may employ a controller350 such as a programmable microprocessor controller, to provide thedescribed functionality.

While the present invention has been disclosed with reference to certainpreferred exemplary embodiments, numerous modifications, alterations,and changes to the described exemplary embodiments are possible withoutdeparting from the sphere and scope of the present invention.Accordingly, it is intended that the present invention not be limited tothe described exemplary embodiments, but that it have the full scope.

1-6. (canceled)
 7. A single-insertion, multiple sample biopsy device,comprising: a stylet extending along a longitudinal axis between adistal end and a proximal end, the stylet having a tip at the distal endand a hollow interior volume extending from a biopsy port proximate thedistal end to the proximal end, the biopsy port being configured toreceive tissue; a cutting cannula that surrounds a portion of the styletand movable along the longitudinal axis; an intermediate sleevecoaxially disposed between the stylet and the cutting cannula, theintermediate sleeve being configured to selectively open and close thebiopsy port; a lumen disposed in the interior volume of the stylet; abulkhead coupled to a distal end of the lumen; a transport subassemblycoupled to the lumen and to the intermediate sleeve to move the bulkheadand the intermediate sleeve relative to each other along thelongitudinal axis between the proximal end and the distal end; and afluid pumping mechanism configured to pump fluid into the hollowinterior volume of the stylet when the intermediate sleeve partly coversthe biopsy port, thereby causing fluid to enter the biopsy port at thedistal end thereof and flow along the stylet in a proximal direction. 8.The device of claim 7, where the transport subassembly includes a firstpulley coupled to the intermediate sleeve via a member and a secondpulley coupled to the bulkhead via the lumen.
 9. The device of claim 8,where the member is in fluid communication with a pressurized salinesource and the lumen is in fluid communication with one or more of avacuum and pressurized fluid source.
 10. The device of claim 9,comprising a marker disposed in one of the stylet tip and the bulkheaddisposed in the stylet, the marker being ejected from at least one ofthe stylet tip and the bulkhead in an operative condition of the device.11. The device of claim 7, where the stylet tip includes a markermounted on the outer surface of the stylet tip, the marker beingseparated from the stylet tip in an operative condition of the device.12. The device of claim 11, where the marker is one or more of a hookedmarker, a helical marker and a serrated edge marker.
 13. The device ofclaim 7, comprising a marker coupled to one of the stylet tip and thebulkhead, where the marker is one of an annular marker and a split-ringmarker. 14-31. (canceled)
 32. A single-insertion, multiple sample biopsydevice, comprising: a cutting sheath, an intermediate sheath, and acannula, the intermediate sheath and the cannula being coaxially alignedwith the cutting sheath that surrounds the intermediate sheath, and theintermediate sheath surrounds the cannula, an annular space beingdefined between the intermediate sheath and the cannula; the cannulahaving a distal end with a port where tissue samples are received and aproximal end where samples are delivered; the intermediate sheathconfigured to move relative to the cannula to selectively open and closethe port; the cannula having a lumen configured to carry a movablebulkhead, the bulkhead being connected to a suction tube; a drivemechanism configured to force the suction tube along the cannula to movethe bulkhead distally and proximally; and a fluid pumping mechanismconfigured to pump fluid into the annular space when the intermediatesheath partly covers the port, thereby causing fluid to enter the portat a distal end thereof and flow along the cannula in a proximaldirection.
 33. The device of claim 32, wherein the drive mechanism andfluid pumping mechanism are configured to be operable in concert to movethe intermediate sheath to partly cover the port, to move the bulkheadproximally, and to convey fluid along the annular space to the portthereby forcing a sample toward the proximal direction.
 34. The deviceof claim 32, further comprising a vacuum pump connected to the suctiontube. 35-45. (canceled)
 46. A biopsy device, comprising: a stylet havinga sample extraction portion and a sample recovery position; a drivemember movable between the sample extraction portion and the samplerecovery position; and a fluid conveyance configured to convey fluidinto the stylet as the drive member is moved from a position distal ofthe sample extraction portion to the sample recovery position sufficientto fill an expanding space remaining distal of the drive member as thedrive member moves from the sample extraction portion to the samplerecovery position.
 47. The device of claim 46, wherein the fluidconveyance is configured to generate a flow of fluid at a rate, the ratebeing lower than a rate required to force a tissue sample along thestylet by hydraulic pressure.
 48. The device of claim 46, wherein thedrive member includes a lumen running along the stylet, the lumenforming a portion of the fluid conveyance.
 49. The device of claim 46,wherein the fluid conveyance includes a lumen within the drive member.50. The device of claim 46, further comprising a frictional drive memberthat engages the drive member to move the drive member along the stylet.51. The device of claim 46, wherein the fluid conveyance is configuredto lubricate the tissue sample engaged by the first bulkhead as thesample is moved along the stylet.
 52. The device of claim 46, furthercomprising a second bulkhead attached to the drive member and locatedproximal of the first bulkhead, with a sample recess defined between thefirst bulkhead and the second bulkhead.